| BackgroundPsoriasis(Psoriasis,Ps)is a common autoimmune-related chronic inflammatory skin disease.China has about more than 500 million patients with psoriasis,the North than the South.According to the clinical features can be divided into psoriasis vulgaris(plaque is the most common type),joint disease type,erythrodermic and pustular,which accounted for more than 99% vulgaris[1].In lesions body surface area(BSA)more than10% of psoriasis criteria as moderate to severe.1984 national epidemiological survey,the percentage of patients with moderate to severe psoriasis was 37.17%.In addition,psoriasis is not only involving the skin,often accompanied by metabolic diseases,cardiovascular diseases,autoimmune diseases and tumors[2].Foreign epidemiological survey showed that lesions in patients with severe disease,the incidence and mortality of cardiovascular disease is higher than the normal population.The pathogenesis of cardiovascular comorbidity may have some relevance[3]psoriatic lesions and inflammation.However,the existing,Means for treatment of psoriasis,the efficacy of most methods can only achieve short-term results were satisfactory,it is difficult to cure,simple topical treatment can not meet the rapid disease control requirements.The efficacy of systemic drugs and phototherapy better,but also long-term accumulation of toxic reaction of fear,and there is poor efficacy in patients with very high scale.So serious condition and ineffective or poor efficacy of traditional treatment patients need to be more active,more effective treatment.In the 1990 s the birth of a monoclonal antibody for the class of biological agents including psoriasis,including the treatment of autoimmune diseases brought revolutionary change.Domestic and foreign registered clinical trials,with moderate to severe plaque psoriasis were treated with TNF-a(TNF-a)antagonists short-termtreatment(12-24 weeks)improvement in psoriatic lesions was significantly better than placebo and conventional systems Drug therapy with methotrexate(MTX)[4].Recent randomized double-blind studies have shown that one of the TNF-a antagonists etanercept(type II receptor extracellular domain and constant IgG immunoglobulin Fc segment of TNF-a formed by the fusion protein,Etanercept)combined with methotrexate methotrexate(MTX)tablets to improve moderate to severe plaque psoriasis lesions was significantly better than etanercept alone.By the Shanghai CITIC-Pharmaceutical Co.,Ltd.independently developed TNF-aantagonists common name recombinant human type II tumor necrosis factor receptor-aantibody fusion protein(common foreign varieties of the same drug called etanercept),commodities named etanercept(Etanercept).In 2005,etanercept injection type eligible for Chinese Food and Drug Administration(CFDA)approved for the treatment of adult rheumatoid arthritis(RA),specifications for the 12.5mg / bottle and 25 mg / bottle,followed by etanercept for treatment of adults with ankylosing spondylitis(AS)and adult plaque psoriasis(Ps)have also approved indications.To validate the clinical efficacy and safety of etanercept and methotrexate treatment of moderate to severe plaque psoriasis,the study conducted a randomized,positive drug controlled study comparing etanercept in combination with methotrexate,etanercept monotherapy in moderate to severe plaque Ps clinical efficacy and safety.ObjectiveTo compare etanercept in combination with methotrexate and etanercept monotherapy in the treatment of moderate to severe plaque psoriasis efficacy and safety.MethodsThe method will be selected with moderate to severe plaque psoriasis in 32 patients were randomly divided into two groups,the experimental group all given etanercept,50 mg,1 times per week by subcutaneous injection,and oral methotrexate,methotrexate from starting dose of 7.5mg,15 mg or 8 weeks to reach the maximum tolerated dose to the patient,24 weeks;the control group received methotrexate universal benefit race simulation agents,usage and test the same group,according to the patient’s age,skinlesions area,erythema extent,depth of invasion,degree scales etc.psoriasis area and severity index(PASI)and lesion surface area(BSA)and Dermatology life quality index(DLQI),a doctor of the disease overall assessment(PGA),the overall patient assessment of disease status(PtGA)and with physical and chemical examination,treatment,comparative analysis of the proportion of patients reached week 24 PASI75,the total effective rate and the proportion reached 12 weeks PASI50,PASI75,PASI90 of24 weeks to reach PASI50,the proportion of patients PASI90,12 weeks and 24 weeks PGA score,PtGA score,DLQI score improvement as well as physical and chemical parameters ESR,CRP to improve the situation,as well as recording and incidence of adverse drug reactions.ResultsThe results of this test were screened enrolled 32 patients with moderate to severe plaque psoriasis patients completed the study treatment and follow-up of 30 cases,including 16 cases of the experimental group,8 males and 8 females,aged 24-61 years old,average 43.62 13.78 years,duration of 36-588 months,an average 197.3 132.6months;the control group of 14 patients,8 males and 6 females,aged 18-69 years,mean 44.93 15.16 years,duration of 60-396 months monthly average 190.5 118.2months.Gender,age,duration of the difference between the two groups were not statistically significant.PASI before treatment difference between the two groups was not statistically significant(P> 0.05);after 24 weeks of treatment,the test group and the control group reached the proportion of patients PASI75 were 93.8% and 57.1%respectively,the difference was statistically significant(P<0.05),the proportion of patients were markedly reach 93.75%,50%,the difference was statistically significant(P<0.05),two groups of 12 weeks to reach PASI50,the proportion of patients PASI75,PASI90 were 100% 81.3%,37.5% and 64.3%,28.6%,14.3%,PASI50,PASI75 difference was statistically significant(P<0.05),PASI90 difference was not statistically significant(P>0.05),two groups of 24 weeks to reach PASI50 the proportion of patients PASI90 were 100%,81.3% and 85.7%,28.6%,PASI50 difference was not statistically significant(P>0.05),PASI90 difference was statistically significant(P<0.05),Week 24,the experimental group Pt GA score improvement than the control group,the difference was statistically significant(P<0.05),two PGA score,DLQI score improvement as well as physical and chemical parameters ESR,CRP to improve the situation of no difference statistically significant(P>0.05),in the whole course of the experiment,the incidence of adverse reactions experimental group and the control group was 56.3% and64.3% respectively,the difference was not statistically significant(P>0.05),in the whole course of the experiment two groups of patients were not occur serious adverse reactions such as tuberculosis,cancer,and so on.ConclusionEtanercept and methotrexate treatment of moderate to severe plaque psoriasis than single treatment with etanercept rapid onset of efficacy,clinical cure rate is high,their safety was no significant difference. |
PDF Full Text Request